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CY503 for the Treatment of Malignant Melanoma Stage IV After Failure of Prior Therapy

Primary Purpose

Melanoma

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
CY-503
Sponsored by
Cytavis Biopharma GmbH
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Stage IV, Phase II

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed, unresectable, Stage IV metastatic melanoma
  • Failure of prior chemotherapy and / or immunotherapy based regimen
  • Measurable disease (based on RECIST criteria)
  • Males and females of at least 18 years of age
  • Women of reproductive potential (defined as being <1 year post-menopausal) must have a negative pregnancy test within 3 days prior to randomization; and men and women of reproductive potential must agree to practice an effective method of avoiding pregnancy
  • Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
  • Life expectancy of at least 3 months
  • WBC ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet count ≥100,000/mm3
  • Bilirubin ≤ 1.5 mg/dL (25.65 μmol/L) (unless due to Gilbert's syndrome in which case the bilirubin should be ≤3.5 mg/dL (59.86 μmol/L)), aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN); hepatic alkaline phosphatase ≤ 3.0 × ULN
  • LDH ≤ 2.5 upper limit of normal (ULN)
  • Serum creatinine ≤ 1.5 mg/dL (132.60 μmol/L), proteinuria < 2.0 g/24 hr urine
  • Patients who have had prior treatment with adjuvant or palliative immunotherapy are eligible provided that therapy ended at least 1 month prior to randomization and all treatment-related toxicities have resolved
  • Patients with bone metastasis should be evaluated by the investigator and prior treatment should be finished at least 1 month prior to randomization
  • Prior radiotherapy (for palliative care only) is allowed provided there is measurable/evaluable disease outside of the radiation field and all radiation-related toxicities have resolved; if there is only one measurable lesion it may not have been irradiated unless subsequent progression has been documented
  • Patients who had prior major surgery are eligible if at least 4 weeks have passed since their surgery and all surgical wounds have healed prior to randomization and at least one measurable tumor is present
  • All toxicities related to prior adjuvant therapy must have resolved
  • Written informed consent

Exclusion Criteria:

  • Pregnancy or nursing
  • Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer
  • Current or planned participation in a research protocol
  • Received an investigational agent within 4 weeks prior to randomization
  • Brain metastases or primary brain tumors, symptomatic pleural effusion or ascites requiring paracentesis
  • Ocular melanoma
  • History of prior malignancies within the past 5 years other than non-melanomatous skin cancers that have been controlled, carcinoma in situ of the cervix, T1a or b prostate cancer noted incidentally during a transurethral resection of prostate (TURP) with prostate-specific antigen (PSA) values within normal limits since TURP, or superficial bladder cancer
  • Any evidence of or history elicited by the investigator of symptomatic cerebrovascular events within 6 months prior to randomization; or any history or evidence of pulmonary embolism or thrombophlebitis requiring anticoagulant therapy
  • Any current evidence of hematemesis, melena, hematochezia, or gross hematuria
  • Elective surgery planned during the study period through 30 days after the last dose of CY-503
  • History of hypersensitivity to previously administered mistletoe
  • Prior therapy with mistletoe
  • History of primary immunodeficiency
  • Known human immunodeficiency virus (HIV) or known active viral hepatic infections
  • Prior treatment with CY-503
  • A general medical or psychological condition or behaviour in the opinion of the investigator, might not permit the patient to complete the study or sign the informed consent.

Sites / Locations

  • Haut Tumor Zentrum Charité
  • Dermatologisches Zentrum Elbe-Klinikum Buxtehude
  • Hautklinik Linden MH Hannover
  • Universitäts-Hautklinik Kiel

Outcomes

Primary Outcome Measures

Tumor assessment by CT and MRT

Secondary Outcome Measures

Immunological response (e.g. measurement of cytokines in serum)
Assessment of quality of life using a standardized questionnaire

Full Information

First Posted
April 9, 2008
Last Updated
June 7, 2011
Sponsor
Cytavis Biopharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00658437
Brief Title
CY503 for the Treatment of Malignant Melanoma Stage IV After Failure of Prior Therapy
Official Title
A Phase II Multicenter Study to Test Progression-free and Overall Survival of CY-503 in the Treatment of Patients With Unresectable Stage IV Metastatic Melanoma After Antineoplastic Treatment Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cytavis Biopharma GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The trial is designed as a phase II evaluation of the effect of CY-503 on progression free survival (PFS) in patients with stage IV malignant melanoma after failure of prior therapy. The aim of the study is at least a rate of 25% (PFS >/= 3 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Melanoma, Stage IV, Phase II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CY-503
Intervention Description
solution for subcutaneous injection, 350 ng twice weekly
Primary Outcome Measure Information:
Title
Tumor assessment by CT and MRT
Time Frame
each 8 weeks
Secondary Outcome Measure Information:
Title
Immunological response (e.g. measurement of cytokines in serum)
Time Frame
each 4 weeks
Title
Assessment of quality of life using a standardized questionnaire
Time Frame
each 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed, unresectable, Stage IV metastatic melanoma Failure of prior chemotherapy and / or immunotherapy based regimen Measurable disease (based on RECIST criteria) Males and females of at least 18 years of age Women of reproductive potential (defined as being <1 year post-menopausal) must have a negative pregnancy test within 3 days prior to randomization; and men and women of reproductive potential must agree to practice an effective method of avoiding pregnancy Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1. Life expectancy of at least 3 months WBC ≥ 3,000/mm3, absolute neutrophil count (ANC) ≥ 1,500/mm3, platelet count ≥100,000/mm3 Bilirubin ≤ 1.5 mg/dL (25.65 μmol/L) (unless due to Gilbert's syndrome in which case the bilirubin should be ≤3.5 mg/dL (59.86 μmol/L)), aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN); hepatic alkaline phosphatase ≤ 3.0 × ULN LDH ≤ 2.5 upper limit of normal (ULN) Serum creatinine ≤ 1.5 mg/dL (132.60 μmol/L), proteinuria < 2.0 g/24 hr urine Patients who have had prior treatment with adjuvant or palliative immunotherapy are eligible provided that therapy ended at least 1 month prior to randomization and all treatment-related toxicities have resolved Patients with bone metastasis should be evaluated by the investigator and prior treatment should be finished at least 1 month prior to randomization Prior radiotherapy (for palliative care only) is allowed provided there is measurable/evaluable disease outside of the radiation field and all radiation-related toxicities have resolved; if there is only one measurable lesion it may not have been irradiated unless subsequent progression has been documented Patients who had prior major surgery are eligible if at least 4 weeks have passed since their surgery and all surgical wounds have healed prior to randomization and at least one measurable tumor is present All toxicities related to prior adjuvant therapy must have resolved Written informed consent Exclusion Criteria: Pregnancy or nursing Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for treatment of cancer Current or planned participation in a research protocol Received an investigational agent within 4 weeks prior to randomization Brain metastases or primary brain tumors, symptomatic pleural effusion or ascites requiring paracentesis Ocular melanoma History of prior malignancies within the past 5 years other than non-melanomatous skin cancers that have been controlled, carcinoma in situ of the cervix, T1a or b prostate cancer noted incidentally during a transurethral resection of prostate (TURP) with prostate-specific antigen (PSA) values within normal limits since TURP, or superficial bladder cancer Any evidence of or history elicited by the investigator of symptomatic cerebrovascular events within 6 months prior to randomization; or any history or evidence of pulmonary embolism or thrombophlebitis requiring anticoagulant therapy Any current evidence of hematemesis, melena, hematochezia, or gross hematuria Elective surgery planned during the study period through 30 days after the last dose of CY-503 History of hypersensitivity to previously administered mistletoe Prior therapy with mistletoe History of primary immunodeficiency Known human immunodeficiency virus (HIV) or known active viral hepatic infections Prior treatment with CY-503 A general medical or psychological condition or behaviour in the opinion of the investigator, might not permit the patient to complete the study or sign the informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Mohr, MD
Organizational Affiliation
Elbe Klinikum Buxtehude, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haut Tumor Zentrum Charité
City
Berlin
ZIP/Postal Code
D-10117
Country
Germany
Facility Name
Dermatologisches Zentrum Elbe-Klinikum Buxtehude
City
Buxtehude
ZIP/Postal Code
D-21603
Country
Germany
Facility Name
Hautklinik Linden MH Hannover
City
Hannover
ZIP/Postal Code
D-30449
Country
Germany
Facility Name
Universitäts-Hautklinik Kiel
City
Kiel
ZIP/Postal Code
D-24105
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25324973
Citation
Trefzer U, Gutzmer R, Wilhelm T, Schenck F, Kahler KC, Jacobi V, Witthohn K, Lentzen H, Mohr P. Treatment of unresectable stage IV metastatic melanoma with aviscumine after anti-neoplastic treatment failure: a phase II, multi-centre study. J Immunother Cancer. 2014 Aug 19;2:27. doi: 10.1186/s40425-014-0027-z. eCollection 2014.
Results Reference
derived

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CY503 for the Treatment of Malignant Melanoma Stage IV After Failure of Prior Therapy

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